Healthy SubjectsPhase 1NCT07144176
PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers
A Phase 1 study testing DWJ1511 and DWC202501 in people with Healthy Subjects, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- DWJ1511 and DWC202501
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2025to Sep 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female participants aged ≥19 years and <65 years at the time of screening
- Body mass index (BMI) between 18 and 30 kg/m² (BMI = weight [kg] / height [m]²)
Who cannot join
- Subjects who have participated in a bioequivalence study or any other clinical trial and have received an investigational product within 6 months prior to the first administration.
- Subjects who have donated whole blood within 8 weeks prior to the first administration, donated blood components within 2 weeks prior to the first administration, or received a blood transfusion within 4 weeks prior to the first administration.
- Subjects with a history of gastrointestinal surgery that may affect drug absorption (appendectomy and hernia repair are not exclusionary).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
H Plus Yangji Hospital
Seoul, 08779
Kang, 82) 070-4665-9476, juspa@newyji.com
About this study
Official title: An Open-label, Randomized, Fasting, Single-dose, Two-treatment, Two-period, Crossover, Phase 1 Clinical Trial to Compare and Evaluate the Pharmacokinetics and Safety of "DWJ1511" and "DWC202501" in Healthy Adult Volunteers
PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers
Read the detailed description
This is an open-label, randomized, single-dose, two-treatment, two-period, crossover, phase 1 clinical trial conducted under fasting conditions to compare and evaluate the pharmacokinetics (PK) and safety of DWJ1511 and DWC202501. in healthy adult volunteers. Participants will receive both study drugs in separate periods, with a washout interval between administrations. The study aims to assess PK parameters and monitor safety through clinical evaluations and laboratory tests.
- Conditions
- Healthy Subjects
- Being tested
- DWJ1511, DWC202501
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWJ1511Drug
Test drug: DWJ1511
DWC202501Drug
Comparator: DWC202501
| Study group | Role | What they receive |
|---|---|---|
| A(RT) | Experimental | 30 Subjects, Cross-over, Single dose DWC202501 on period 1, Single dose of DWJ1511 on period 2 Receives: Drug: DWJ1511; Drug: DWC202501 |
| B(TR) | Active comparator | 30 Subjects, Cross-over, Single dose DWJ1511 on period 1, Single dose of DWC202501 on period 2 Receives: Drug: DWJ1511; Drug: DWC202501 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma drug concentration-time curve [AUCt]
Area under the plasma drug concentration-time curve [AUCt] of DWJ1511 and DWC202501
Measured: 0-12 Hours
Maximum plasma concentration [Cmax]
Maximum plasma concentration [Cmax] of DWJ1511 and DWC202501
Measured: 0-12 Hours
Secondary outcomes (1)
Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]
Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] of DWJ1511 and DWC202501
Measured: 0-12 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144176
- Sponsor's protocol ID
- DW_DWJ1511101
- Status last verified
- Aug 2025
- First submitted
- 20 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Fasting, Single-dose, Two-treatment, Two-period, Crossover, Phase 1 Clinical Trial to Compare and Evaluate the Pharmacokinetics and Safety of "DWJ1511" and "DWC202501" in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT07144176
- Acronym / sponsor ID
- DW_DWJ1511101
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 27 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers
Detailed description
This is an open-label, randomized, single-dose, two-treatment, two-period, crossover, phase 1 clinical trial conducted under fasting conditions to compare and evaluate the pharmacokinetics (PK) and safety of DWJ1511 and DWC202501. in healthy adult volunteers. Participants will receive both study drugs in separate periods, with a washout interval between administrations. The study aims to assess PK parameters and monitor safety through clinical evaluations and laboratory tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A(RT) | Experimental | Drug: DWJ1511, Drug: DWC20250130 Subjects, Cross-over, Single dose DWC202501 on period 1, Single dose of DWJ1511 on period 2 |
| B(TR) | Active comparator | Drug: DWJ1511, Drug: DWC20250130 Subjects, Cross-over, Single dose DWJ1511 on period 1, Single dose of DWC202501 on period 2 |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male or female participants aged ≥19 years and <65 years at the time of screening
- Body mass index (BMI) between 18 and 30 kg/m² (BMI = weight [kg] / height [m]²)
Key exclusion criteria (3 listed)
- Subjects who have participated in a bioequivalence study or any other clinical trial and have received an investigational product within 6 months prior to the first administration.
- Subjects who have donated whole blood within 8 weeks prior to the first administration, donated blood components within 2 weeks prior to the first administration, or received a blood transfusion within 4 weeks prior to the first administration.
- Subjects with a history of gastrointestinal surgery that may affect drug absorption (appendectomy and hernia repair are not exclusionary).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DWJ1511Test drug: DWJ1511 | Drug | A(RT), B(TR) |
| DWC202501Comparator: DWC202501 | Drug | A(RT), B(TR) |
Primary outcome
Area under the plasma drug concentration-time curve [AUCt]
Time frame: 0-12 Hours
Area under the plasma drug concentration-time curve [AUCt] of DWJ1511 and DWC202501
Maximum plasma concentration [Cmax]
Time frame: 0-12 Hours
Maximum plasma concentration [Cmax] of DWJ1511 and DWC202501
1 secondary outcome
Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]
Time frame: 0-12 Hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DWJ1511 and DWC202501 in people with Healthy Subjects, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kang (82) 070-4665-9490, juspa@newyjh.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma drug concentration-time curve [AUCt] (time frame: 0-12 Hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.